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First Vioxx Lawsuit: Entryway into a Legal Labyrinth

In a small town in South Texas, a long legal journey will begin this week for Merck, the giant drug maker, and thousands of people who suffered heart attacks and strokes after taking its painkiller Vioxx.

On Thursday, opening arguments are expected to start in a state court in Angleton, Tex., in Ernst v. Merck, the first civil case to reach trial among thousands of suits that people who took Vioxx or their families have filed against Merck. In the suit, the wife and children of Robert Ernst contend that Vioxx caused Mr. Ernst to die in bed on May 6, 2001.

Assuming that the case is not settled before trial – a possibility both sides discount – a Texas state district judge, Ben Hardin, and a 12-member jury can be expected to hear two starkly differing views of Merck and the way it researched and marketed Vioxx.

As the first trial in what could become the biggest and most expensive civil litigation since the tobacco lawsuits of the late 1990’s, the case is expected to attract widespread attention from Wall Street, the news media and lawyers. At least one drug industry analyst, C. Anthony Butler of Lehman Brothers, says that he plans to attend the trial so he can see Merck’s potential liability at first hand.

Using company documents, including e-mail messages between top Merck scientists, the Ernsts’ lawyer, W. Mark Lanier, will try to show that Merck knew of Vioxx’s heart risks before the drug was approved in 1999 and failed to conduct necessary scientific studies. As a result, Mr. Lanier said in an interview on Friday, Vioxx remained on the market for five years and caused countless heart attacks and strokes before Merck withdrew it in 2004.

“They let a drug out that they knew would kill lots of people,” Mr. Lanier asserted. “It’s a real pity, too, because Merck had been a real good company.”

Lawyers for Merck will argue that the drug maker acted responsibly by removing Vioxx from the market as soon as a clinical trial showed that it was riskier than a placebo. Merck will also maintain that although Vioxx has been associated with an increased risk of heart attacks, there is no evidence that it caused Mr. Ernst’s death. A county medical examiner found that Mr. Ernst died of an arrhythmia, or irregular heartbeat, and Merck says that no evidence links Vioxx to arrhythmias.

Theodore V. H. Mayer, a partner at Hughes Hubbard & Reed, the law firm coordinating Merck’s defense, said: “We believe very strongly that the company behaved responsibly and has a strong story to tell. We think the plaintiffs have a high barrier to prove their case.”

Because about 20 million Americans took Vioxx before it was withdrawn, Merck faces potentially enormous liabilities if lawyers like Mr. Lanier can convince juries that the company is responsible for heart attacks and strokes among people who used the drug. Wyeth, the maker of fenfluramine, a diet drug that was withdrawn from the market in 1997 after being linked to heart-valve damage, has already taken $21 billion in charges to its earnings related to suits filed by people who took the drug.

At a hearing in New Orleans in May, United States District Judge Eldon Fallon, who is overseeing the cases filed in federal court, predicted that as many as 100,000 people might file suits against Merck. Some plaintiffs’ lawyers say that estimate may be too high, predicting that no more than 25,000 claims will be filed. About 4,000 individual claims have been filed so far, the company says. Still, since Merck withdrew Vioxx at the end of September, its shares have fallen by about 30 percent, shaving some $30 billion off the company’s value.

Still, both plaintiffs’ and defense lawyers caution against reading too much into the outcome of this case. Wyeth’s seemingly unending payments to settle fenfluramine cases have caused other drug companies to become more aggressive about defending their cases in court, and several have had significant successes. In 2003, Bayer overcame a number of damaging internal documents and won a lawsuit in Texas brought by an 82-year-old man who said he had suffered muscle damage after taking its cholesterol-lowering drug Baycol. That victory helped limit Bayer’s liability in the Baycol cases, analysts say.

Facing a potentially vast number of Vioxx claimants, Merck has said that it will not settle cases and will force plaintiffs to win verdicts in court. As a result, plaintiffs’ lawyers are planning to try dozens or hundreds of cases, no matter what happens in the Ernst case, said Christopher A. Seeger, whose law firm, Seeger Weiss, is a lead plaintiffs’ counsel in the federal suits overseen by Judge Fallon.

“If Mark wins this case,” Mr. Seeger said, referring to Mr. Lanier, “we’re still going to have to continue to try cases, and if he loses the case, the same thing. We have to be prepared to try a lot.”

Mr. Mayer, the coordinating lawyer for Merck, agreed that the Ernst trial would probably be only the first of many. “Every case has to be looked at individually,” he said, “and it’s going to be tried on its own facts. We expect to be trying these cases one by one and for a long time.”

The Ernst case has pitfalls for both sides. Mr. Lanier, whose folksy style is balanced by intellect and toughness, is widely considered one of the best trial lawyers in the United States. He has won big verdicts before in Angleton, a semirural area about 45 miles south of Houston. Further, many Merck documents that have been produced by the company in the pretrial discovery process show that its top scientists were worried about heart risks from Vioxx, and considered and rejected conducting specific studies to examine those risks.

Still, to win the case, Mr. Lanier must convince a jury not just that Vioxx is dangerous, but that it actually caused the arrhythmia that led to Mr. Ernst’s death.

Merck will argue that it properly disclosed Vioxx’s risks to regulators and doctors.

“The information was out there for the medical and scientific community,” Mr. Mayer said. “We believe if you look at the totality of what was actually done, you see a company that was devoted to safety.”

Mr. Lanier said that he expected to win the case but that this would not be his last Vioxx lawsuit either way. The history of complex product liability cases, like the suits filed over asbestos or tobacco, shows that plaintiffs get stronger as the litigation continues, he said, adding: “You learn from each one. You need to see what’s important to jurors and what’s not.”

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